In many hospitals, the operating room plays an important role in the care that is provided to patients. The operating room is generally designed to accommodate multiple surgical specialties and their associated surgical staff and surgical equipment
While the operating room has the potential to be used to save a patient's life, the risks associated with the operating room are quite high because the patient may suffer serious injury and/or death if aspects of the operating room are not correct. For example, there may be serious health consequences if the designated portion of the operating room is not maintained sterile.
Because of the costs of the equipment used in the operating room and the precautions that must be taken to protect the patient such as from infection, the operating room is very costly. There are also significant costs associated with the persons who perform and/or assist with surgeries.
Most hospitals receive a large portion of their revenue from insurance companies and/or governmental agencies. These organizations will often impose strict guidelines on how much revenue the hospital receives for performing particular procedures. Accordingly, the hospitals must balance patient care with cost concerns.
The space within the operating room is typically quite limited as the operating room may have an area of between about 300 square feet and about 550 square feet. This limited size presents challenges in view of the proliferation of advanced technology that has been introduced for the operating room over the past decade.
Technological developments have resulted in a dramatic increase in the number and complexity of operating room equipment and supplies. This equipment and supplies can lead to clutter in the operating room, which can present a significant challenge to patient safety in the operating room environment.
For example, heavy or large equipment that may be either permanently installed or moved into and out of the operating room during an operation. This equipment can create obstacles to movement of staff and equipment within the operating.
Furthermore, electrical wiring, vacuum tubes, gas hoses and garbage receptacles may be present in the operating room. These items represent serious safety hazards to surgeons, nurses, technicians and patients. Intra-operative complications due to staff injury and equipment dislocation have caused dramatic clinical consequences for patients and liability for both physicians and hospitals.
The lack of real-time information on the patient and the applicable surgical procedures has resulted in an environment that is inefficient. These inefficiencies lead to lost time and hospital errors when critical data is missing and/or inaccessible.
Sharing of patient information, radiology studies, test results, and pathology reports is limited. Despite the technological digital revolution that has taken place in our offices and our homes, operating room information technology has progressed little in the last thirty years.
Surgical device manufacturers produce the surgical devices and distribute the surgical devices with instructions for using the surgical devices. In many countries, the surgical devices and the instructions for using the surgical devices must be approved by a governmental regulatory organization before the surgical devices may be distributed.
For example, in the United States, the Food and Drug Administration is the governmental regulatory organization that reviews surgical devices. Depending on the type of surgical device, the request for approval to distribute medical devices generally falls within either a PMA or a 510 k.
Hospitals may require the surgeon to be trained on the procedures associated with the use and/or implantation of the surgical device. This training is typically done by the company that manufactures, distributes and/or imports the surgical device.
In addition to the surgeon, there are typically several other persons present in the operating room while the surgical procedure is being performed. One such person in the operating room is a surgical technologist who has the responsibility of ensuring that the items that will be needed when performing the surgical procedure are provided to the surgeon at the appropriate time and in a sterile environment.
It was previously customary for a surgical technologist to be assigned to a particular surgeon(s). In such situations, the surgical technologist was typically able to become familiar with the surgical procedures that were performed by the surgeon(s) to which he/she was assigned. The surgical technologist thereby gained familiarity with the surgical devices, surgical instruments and other associated items that were used by the assigned surgeon(s) thereby leading to an efficient surgical procedure.
There has been a trend away from assigning surgical technologists to particular surgeons. Rather, the surgical technologists have an assigned work schedule. While the surgical technologist is on-duty, the surgical technologist may participate in a variety of surgical procedures that are performed by a variety of surgeons.
In view of the preceding changes, it may be more challenging for the surgical technologist to gain a high degree of familiarity with the surgical instruments that are used in conjunction with all of the surgical procedures on which the surgical technologist assists.
Another issue that affects the ability of the surgical technologist to become familiar with surgical instruments that are used when performing particular surgical techniques is the fact that there is a high degree of turnover with surgical technologists. Recent data reflects a turnover rate of 14% for surgical technologists (2008 NCHA Workforce Report, April 2009; Sarah J. Broome, PhD. Director of Economic Research, North Carolina Hospital Association)
Some of the most complex surgeries are orthopedic and spine procedures. These procedures may take 2-4 hours to complete and require the use of complex instrument sets. To enhance the ability to handle the complex instrument sets, the instruments may be placed into trays. These comments also apply to implants that are used in conjunction with the surgical procedures.
The instruments may be organized into particular trays based upon the procedure with which the instruments are intended to be used. For example, in total joint surgeries there may be separate trays for femoral and tibial instruments.
In an effort to overcome the surgical technologist not being familiar with the surgical instruments used in a particular procedure, a representative from the manufacturer of the surgical device and/or instrument may be present in the operating room while the surgical procedure is being performed so that the representative could answer questions relating to the selection of the particular surgical devices and/or instruments.
It is desirable to minimize the number of people within the sterile field in the operating room because such additional people may increase the risk of patent infection as well as potentially interfere with the movement of the people in the sterile field performing the surgical procedure or assisting in the surgical procedure.
In view of the preceding comments, it is customary for the surgical device/instrument representative to be outside of the sterile field in the operating room. Because of this position, the representative is not able to directly point at the surgical instrument. Rather, the representative will typically use a pointing device to identify a particular surgical instrument. One such suitable pointing device is a laser pointer that enables the surgical instrument to be identified without placing any objects into the sterile field.
While such a technique ensures that the surgical instruments are promptly and accurately provided to the surgeon, the presence of the surgical device/instrument representative in the operating room represents a significant cost to the surgical device/instrument manufacturer and/or representative and a potential distraction for the surgical team.
In the case where the costs are born by the surgical device/instrument manufacturer, such additional cost must be incorporated into the prices of the surgical devices and/or instruments.
In the case where the costs are born by the representative, the representative loses selling time that may be used for calling on other customers. Such a reduction in promotional activities can lead to a reduction in income for the representative.
In an attempt to overcome the preceding effects on the representative, some representatives hire associates to be present in the operating room during the surgical procedures in which the surgical devices/instruments are used. This associate representative is trained on the surgical instruments and the order in which the surgical instruments are used during particular surgical procedures.
Even though the compensation for the associate representative is generally less than the compensation of the representative, the compensation for the associate representative still is a significant expense that must be paid by the surgical device/instrument manufacturer and/or representative.
As is referenced above, surgical instruments may be provided by the manufacturer in trays based upon the type of surgical procedure the surgical instruments are intended to be used with. While the surgical instruments may be provided by the manufacturer or distributor in a clean configuration, they are generally not provided in a sterile configuration.
Even if the surgical instruments were provided in a sterile configuration, it is the procedure of many hospitals to resterilize the surgical instruments so that the hospital can guarantee the sterility of the surgical instruments when they are used in conjunction with a surgical procedure.
Hospitals have a Central Sterile Supply department that is dedicated to sterilizing surgical instruments. This department may be located within the hospital to minimize the potential of the surgical instruments being exposed to pathogens and/or environmental elements such as rain that could impact the sterility of the surgical instruments.
When the surgical instruments are received in the sterilization department, the surgical instruments are generally removed from the trays in which the surgical instruments are delivered from the manufacturer or distributor. The surgical instruments are then processed through the sterilization process such as by using an autoclave.
Once the surgical instruments are sterilized, the surgical instruments must be reassembled into the correct position in the correct surgical instrument tray. To assist the sterilization staff to correctly reassemble the surgical instruments into correct way and in the correct surgical instrument tray, images of the correctly assembled surgical instrument trays may be displayed in the surgical department.